scholarly journals Use of Low Dos Aspirin in Women with Increased Risk of Preeclampsia

2020 ◽  
Vol 6 (6) ◽  
pp. 125-130
Author(s):  
Dr. Chetna R Vaghela ◽  
◽  
Dr. Vipul Nanjibhai Sarvaiya ◽  
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Double Blind ◽  
Intention To Treat ◽  
Increased Risk ◽  
Lost To Follow Up ◽  
Singleton Pregnancies ◽  
Aspirin Group

Introduction: The role of aspirin in the primary or secondary prevention of preeclampsia has beenthe subject of numerous studies and great controversy. Our aim reports on LDA usage rates bywomen with an increased PE risk, as well as on determinants and reasons given for use and non‐use. Material and Method: In this multicenter, double-blind, placebo-controlled trial, the currentstudy randomly assigned 2100 women with singleton pregnancies who were at high risk for pretermpreeclampsia to receive aspirin, at a dose of 150 mg per day, or placebo from 11 to 14 weeks ofgestation until 36 weeks of gestation. The primary outcome was delivery with preeclampsia before37 weeks of gestation. The analysis was performed according to the intention-to-treat principle.Results: Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as comparedwith 35 (4.3%) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval,0.20 to 0.74; P=0.004). Results were materially unchanged in a sensitivity analysis that took intoaccount participants who had withdrawn or were lost to follow-up. Conclusion: This randomizedtrial showed that among women with singleton pregnancies who were identified using first-trimesterscreening as being at high risk for preterm preeclampsia, the administration of aspirin at a dose of150 mg per day from 11 to 14 weeks of gestation until 36 weeks of gestation resulted in asignificantly lower incidence of preterm preeclampsia than that with placebo.

scholarly journals Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial

2020 ◽  
Author(s):  
Christiane Maria Prado Jeronimo ◽  
Maria Eduarda Leão Farias ◽  
Fernando Fonseca Almeida Val ◽  
Vanderson Souza Sampaio ◽  
Marcia Almeida Araújo Alexandre ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Tertiary Care ◽  
Care Facility ◽  
Hospitalized Patients ◽  
Double Blind ◽  
Intention To Treat ◽  
Virus Clearance ◽  
Tertiary Care Facility ◽  
Short Course

Abstract Background Steroid use for coronavirus disease 2019 (COVID-19) is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. Methods A parallel, double-blind, placebo-controlled, randomized, Phase IIb clinical trial was performed with hospitalized patients aged ≥18 years with clinical, epidemiological, and/or radiological suspected COVID-19 at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution) twice daily for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. Results From 18 April to 16 June 2020, 647 patients were screened, 416 were randomized, and 393 were analyzed as mITT, with 194 individuals assigned to MP and 199 to placebo. SARS-CoV-2 infection was confirmed by reverse transcriptase polymerase chain reaction in 81.3%. The mortality rates at Day 28 were not different between groups. A subgroup analysis showed that patients over 60 years old in the MP group had a lower mortality rate at Day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until Day 7. Conclusions The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population. Clinical Trials Registration NCT04343729.

scholarly journals Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial

BMJ ◽  
2021 ◽  
pp. e068060
Author(s):  
Nicole Ezer ◽  
Sara Belga ◽  
Nick Daneman ◽  
Adrienne Chan ◽  
Benjamin M Smith ◽  
...  
Keyword(s):  
Respiratory Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dose Inhaler ◽  
Control Group ◽  
Double Blind ◽  
Adjusted Risk ◽  
Intention To Treat ◽  
Treat Population

Abstract Objective To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19. Design Randomised, double blind, placebo controlled trial. Setting Three Canadian provinces (Quebec, Ontario, and British Columbia). Participants 203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea. Intervention Participants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days. Main outcome measures The primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex. Results The modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval −7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered. Conclusion Compared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed. Trial registration ClinicalTrials.gov NCT04435795 .

Double Blind Comparison of Mefenamic Acid and Acetaminophen (Paracetamol) in Migraine

Cephalalgia ◽  
1983 ◽  
Vol 3 (2) ◽  
pp. 129-134 ◽  
Author(s):  
R. C. Peatfield ◽  
R. G. Petty ◽  
F. Clifford Rose
Keyword(s):  
Mefenamic Acid ◽  
Analogue Scale ◽  
Double Blind ◽  
Inflammatory Drug ◽  
Pain Pathways ◽  
The Mean ◽  
Blind Comparison ◽  
Lost To Follow Up

We have assessed the role of mefenamic acid, a non-steroidal anti-inflammatory drug known to inhibit both the synthesis and actions of prostaglandins, as an analgesic in migraine by comparing it with the established analgesic paracetamol (acetaminophen) in a double-blind cross-over trial. Forty ambulant migraine patients were supplied with oral meditation for six consecutive attacks; metoclopramide 10 mg was administered in all attacks, and paracetamol 500 mg and mefenamic acid 500 mg for three attacks each. The patients recorded the intensity of the headache at the time the meditation was taken, and again after 3 hours, on a linear analogue scale. Twenty-two patients completed the trial satisfactorily. Seven had insufficient attacks and the remainder were lost to follow-up. The mean reduction in headache intensity was 36 ± 11% on mefenamic acid and 27 ± 10% (both mean ± SEM) on paracetamol. While this difference is not quite statistically significant (0.1 > P > 0.05) there still remains a 28% probability that mefenamic acid is twice as potent as an analgesic. The responses in each individual patient to the two drugs were very closely correlated (P < 0.001). Our failure to demonstrate a convincing difference between the two analgesics leads us to speculate that peripheral prostaglandin mediated pain pathways, in which paracetamol is inactive, may be less important than central pathways, which are inhibited by both drugs.

scholarly journals Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Julia C Dombrowski ◽  
Michael R Wierzbicki ◽  
Lori M Newman ◽  
Jonathan A Powell ◽  
Ashley Miller ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Care ◽  
Nucleic Acid Amplification ◽  
Absolute Difference ◽  
Complete Case ◽  
Double Blind ◽  
Intention To Treat ◽  
Sex With Men

Abstract Background Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective. Methods This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants. Results Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16–36%; P &lt; .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9–31%; P &lt; .001). Conclusions A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM. Clinical Trials Registration ClinicalTrials.gov (NCT03608774).

scholarly journals Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1276
Author(s):  
Franka Neumer ◽  
Orenci Urraca ◽  
Joaquin Alonso ◽  
Jesús Palencia ◽  
Vicente Varea ◽  
...  
Keyword(s):  
Infant Formula ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
First Year ◽  
Double Blind Study ◽  
Double Blind ◽  
Term Infants ◽  
Intention To Treat ◽  
Prebiotic Oligosaccharides ◽  
First Year Of Life

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.

Double-Blind, Placebo-Controlled Trial of Oral Immunotherapy (OIT) in Peanut (PN) Allergic Children: A Follow-up

2010 ◽  
Vol 125 (2) ◽  
pp. AB58 ◽  
Author(s):  
S.M. Jones ◽  
A.M. Scurlock ◽  
L. Pons ◽  
T.T. Perry ◽  
A.R. Morgan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Oral Immunotherapy ◽  
Double Blind ◽  
Double Blind Placebo

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

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